Invokana

FDA Requires Warning as Invokana Is Linked to Deadly Side Effects

Janssen Pharmaceuticals diabetes drug Invokana (canagliflozin) has become the subject of multiple lawsuits following an FDA decision that requires the drug to carry strict warnings for diabetic ketoacidosis, potentially fatal blood infections, and impaired kidney function.

FDA ORDERS UPDATED PRODUCT LABELS FOR INVOKANA

In May 2015, U.S. Food and Drug Administration (FDA) issued a warning that Invokana can result in diabetic ketoacidosis (DKA). DKA is a condition in which the body is unable to use glucose due to a lack of insulin. As a result, the body begins to break down fat for energy. This produces ketones, a waste product, which builds up in the body and becomes toxic.

The condition can result in swelling of the brain, severe dehydration, coma, and death.

The FDA reported that they had received 20 reports of DKA in Type 2 diabetes patients being treated with SGLT2 inhibitors (Invokana and others), and 73 reports of DKA in both Type 1 and Type 2 diabetes patients taking the drug.

As a result of their findings, the FDA ordered that Janssen update Invokana’s product label to acknowledge the risk of DKA in December 2015.

In May 2016, the FDA issued yet another warning regarding Invokana and its sister drug Invokamet stating that both medications had been linked to an increased risk of leg, foot, and toe amputations. The regulatory authority is still working to determine just how great the risk is.

INVOKANA LINKED TO OTHER SERIOUS ADVERSE EVENTS

DKA is not the only potentially fatal outcome for patients taking Invokana. In December 2015, the FDA ordered Invokana’s label address life-threatening blood infections and kidney failures. The regulator reported that it had identified at least 19 instances of life-threatening blood infections and kidney failures, all originating from UTIs.

In January 2016, the Institute for Safe Medication Practice (ISMP) reported that it had linked 5,484 adverse events related to Invokana in 2015 alone – more than 92% of all other drugs regularly monitored by the ISMP.